MENOPUR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MENOPUR (MENOPUR).
Menotropins (MENOPUR) contain follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity, which stimulate ovarian follicular growth and maturation in women, and spermatogenesis in men with hypogonadotropic hypogonadism.
| Metabolism | Metabolism is not fully characterized; renally excreted as intact protein. |
| Excretion | Primarily renal excretion of unchanged drug and metabolites; approximately 80% of a dose is excreted in urine within 24 hours, with the remainder excreted in feces via biliary elimination. |
| Half-life | The terminal elimination half-life is approximately 30-40 hours for FSH activity, reflecting the prolonged effect on follicular development; clinical dosing is adjusted based on response. |
| Protein binding | Approximately 10-20% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.5-0.6 L/kg, indicating distribution primarily into extracellular fluid and limited tissue binding. |
| Bioavailability | Subcutaneous or intramuscular: Approximately 70-80% due to partial local degradation; oral bioavailability is negligible (<1%). |
| Onset of Action | Subcutaneous or intramuscular injection: Serum FSH levels rise within 1-2 hours, with follicular growth detectable by ultrasound after 5-7 days of daily administration. |
| Duration of Action | The duration of effect on follicular growth persists for several days after the last injection; clinical monitoring continues until ovulation is induced or cycle is completed. |
| Action Class | Gonadotropins |
| Brand Substitutes | Ovulate-M 75IU Injection, Menovul 75IU Injection, Hmg SP 75IU Injection, Menosar HP 75IU Injection, Menogon Injection |
225 IU subcutaneously or intramuscularly once daily starting on day 2-3 of cycle, adjusted after 5 days based on response; maximum daily dose 450 IU.
| Dosage form | INJECTABLE |
| Renal impairment | No specific guidelines; use with caution in severe renal impairment (GFR <30 mL/min) due to limited data, consider risk of fluid retention. |
| Liver impairment | No specific guidelines; contraindicated in severe hepatic impairment (Child-Pugh class C) as metabolism is hepatic; use with caution in Child-Pugh class B. |
| Pediatric use | Not indicated; no established pediatric dosing. |
| Geriatric use | Not indicated for geriatric patients; no dosing recommendations. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MENOPUR (MENOPUR).
| Breastfeeding | Menotropins are not indicated during lactation due to lack of data. It is unknown if menotropins are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during therapy. M/P ratio is unknown. |
| Teratogenic Risk | Menopur (menotropins) is a gonadotropin preparation used for ovulation induction. Fetal risk in the first trimester is associated with an increased incidence of neural tube defects, congenital heart defects, and multiple anomalies, likely related to the underlying infertility and assisted reproductive technology rather than direct teratogenicity. Second and third trimester risks include preterm labor, low birth weight, and perinatal mortality due to multiple gestation and ovarian hyperstimulation syndrome (OHSS). |
■ FDA Black Box Warning
MENOPUR should only be used by physicians who are experienced in infertility diagnosis and management. Use may cause ovarian hyperstimulation syndrome (OHSS), which can be severe and result in pulmonary embolism, stroke, ovarian torsion, or death. Use should be avoided in women with a high baseline FSH level indicating primary ovarian failure.
| Serious Effects |
["Hypersensitivity to menotropins or any component.","High baseline FSH indicating primary ovarian failure.","Uncontrolled thyroid or adrenal dysfunction.","Organic intracranial lesion (e.g., pituitary tumor).","Abnormal uterine bleeding of undetermined origin.","Ovarian cysts or enlargement of undetermined origin (not due to PCOS).","Sex hormone-dependent tumors (e.g., ovarian, breast, uterine).","Pregnancy and lactation."]
| Precautions | ["Ovarian Hyperstimulation Syndrome (OHSS) - risk minimized by monitoring estradiol levels and ultrasound; discontinue if severe.","Multiple pregnancy - high risk; counseling is required.","Ovarian enlargement - usually resolves without treatment.","Pulmonary embolism and arterial thromboembolism - especially in severe OHSS.","Ovarian torsion - consider in patients with severe OHSS.","Ectopic pregnancy - increased risk in patients with tubal disease.","Congenital malformations - incidence similar to natural conception.","Ovarian neoplasms - no definitive causal link, but caution."] |
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| Fetal Monitoring | Monitor for ovarian hyperstimulation syndrome (OHSS) via ultrasound and estradiol levels. Assess multiple gestation with early ultrasound. During pregnancy, monitor for signs of OHSS, ectopic pregnancy, and spontaneous abortion. Fetal monitoring includes serial ultrasounds for growth and anatomy, and consider prenatal diagnostic testing for neural tube defects and chromosomal anomalies. |
| Fertility Effects | Menopur is used for ovulation induction in women undergoing assisted reproductive technology. It increases the risk of multiple gestation (up to 20%), ovarian hyperstimulation syndrome, ectopic pregnancy, and spontaneous abortion. It does not have known long-term adverse effects on fertility, but underlying conditions may persist. |